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FDA Warning Letter for inadequate Batch Record

Review
The U.S. Food and Drug Administration (FDA) recently posted a Warning Letter for a Chinese API
manufacturer criticising the quality unit for not exercising its responsibility adequately.

For example, batch production records

"contained blank or partially completed manufacturing data"


"lacked dates and signatures for verification"
"contained sticky notes from the quality assurance department directing operators to enter
manufacturing data"
were not approved by the quality unit

Also other documents like, for example, cleaning records and equipment use logs were found "without dates
and signatures for verification, or with pages or spaces intentionally left blank for documentation at a later
time".

As a conclusion, FDA stated that these "significant inspection findings indicate that your quality unit is not
fully exercising its authority and/or responsibilities". And FDA placed the company on Import Alert.